EP1695664B1 - Medical needle and medical device - Google Patents

Medical needle and medical device Download PDF

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Publication number
EP1695664B1
EP1695664B1 EP04807140A EP04807140A EP1695664B1 EP 1695664 B1 EP1695664 B1 EP 1695664B1 EP 04807140 A EP04807140 A EP 04807140A EP 04807140 A EP04807140 A EP 04807140A EP 1695664 B1 EP1695664 B1 EP 1695664B1
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EP
European Patent Office
Prior art keywords
cross
lancet
section
medical needle
region
Prior art date
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Application number
EP04807140A
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German (de)
English (en)
French (fr)
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EP1695664A1 (en
EP1695664A4 (en
Inventor
Mitsuo Fukuda
Seiji Aoyagi
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Lightnix Inc
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Lightnix Inc
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Publication of EP1695664A4 publication Critical patent/EP1695664A4/en
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/14—Devices for taking samples of blood ; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood
    • A61B5/1405—Devices for taking blood samples
    • A61B5/1411—Devices for taking blood samples by percutaneous method, e.g. by lancet
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/150022—Source of blood for capillary blood or interstitial fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150053—Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
    • A61B5/150061—Means for enhancing collection
    • A61B5/150099—Means for enhancing collection by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150053—Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
    • A61B5/150106—Means for reducing pain or discomfort applied before puncturing; desensitising the skin at the location where body is to be pierced
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150229—Pumps for assisting the blood sampling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150274—Manufacture or production processes or steps for blood sampling devices
    • A61B5/150282—Manufacture or production processes or steps for blood sampling devices for piercing elements, e.g. blade, lancet, canula, needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150389—Hollow piercing elements, e.g. canulas, needles, for piercing the skin
    • A61B5/150396—Specific tip design, e.g. for improved penetration characteristics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150389—Hollow piercing elements, e.g. canulas, needles, for piercing the skin
    • A61B5/150404—Specific design of proximal end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
    • A61B5/150419—Pointed piercing elements, e.g. needles, lancets for piercing the skin comprising means for capillary action
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
    • A61B5/150427—Specific tip design, e.g. for improved penetration characteristics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150442—Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
    • A61B5/150458—Specific blade design, e.g. for improved cutting and penetration characteristics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150503—Single-ended needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150503—Single-ended needles
    • A61B5/150511—Details of construction of shaft
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3286—Needle tip design, e.g. for improved penetration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/42—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for desensitising skin, for protruding skin to facilitate piercing, or for locating point where body is to be pierced
    • A61M5/422—Desensitising skin

Definitions

  • the present invention relates to a medical needle such as a lancet and needle and to a medical device using thereof, and in particular, relates to the medical needle made of biocompatible material and to the medical device using thereof.
  • a needle is shot at an appropriate portion of the body such as skin and muscle to inject medicine inside the patient.
  • a diabetic uses a lancet to sample a small amount of his or her blood by stinging it on any suitable portions, e.g., at fingertip, for routine measurement of blood sugar.
  • a substantial area of cells around the tingled portion may often be damaged, requiring some time to be healed. Therefore, there has been long-felt desire to develop a less invasive injection needle and lancet, minimizing the pain (unpleasantness) experienced by the patient.
  • JPA 10-57490 explains the primary reason of the patient's pain that the needle tip "catches" the skin or flesh as the injection needle is penetrating. Also, it discloses a hypodermic injection needle with multi-beveled tip geometry so as to reduce the pain.
  • Patent Document 1 JPA 10-57490 US 3,492,992 relates to a hypodermic needle including a channel for conveying fluid.
  • EP 1346686 relates to a fluid collection apparatus having an integrated lancet and reaction area.
  • the present inventors have found the reason of the pain more precisely as described below, and made the invention based upon the knowledge.
  • a contacting surface between an outer surface of the injection needle and the tissue of the patient is increased so that the frictional force therebetween becomes greater and the peripheral cells adjacent to the injection needle are drawn inside deeply.
  • the peripheral cells are extremely deformed by the physical stress due to the frictional force, and may often be burst away (collapsed) so that a pain-producing chemical mediator such as histamine and bradykinin is released within the tissue, thereby hurting the patient.
  • the peripheral cells collapsed by the physical stress extend across the substantial region, which makes more painful and less healable.
  • the conventional injection needle is highly invasive to pierce the tissue of the patient.
  • the lancet is used to sample a drop of blood by stinging into the tissue at the appropriate portion of the patient's body.
  • the lancet designed less invasive by minimizing the frictional stress to the peripheral tissue of the patient.
  • the medical needle of the present invention cuts the peripheral cells as few as possible and wedges away the intact tissues into the deep inside, as will be described herein in detail.
  • one of the aspects of the present invention is to provide a less invasive medical needle giving less pain to the patient.
  • the first aspect of the present invention provides a medical needle extending along a predetermined direction and having a vertical cross-section taken along a plane perpendicular to the predetermined direction of which cross-sectional area varies based upon a distance from a needle tip.
  • the medical needle includes a plurality of maximal points where the cross-sectional area of the vertical cross-section is locally maximal, and a plurality of minimal points arranged between the maximal point closest to the needle tip and a needle rear, wherein the cross-sectional area of the vertical cross-section is locally minimal and wherein each of said plurality of minimal points is arranged between a pair of adjacent maximal points.
  • the vertical cross-section at the maximal point closest to the needle tip has the cross-sectional area not less than those at any other maximal points.
  • the vertical cross-section between the needle tip and the maximal point closest to the needle tip is gradually and continuously increased in accordance with the distance from the needle tip.
  • the medical needle further includes at least one channel formed therein extending along the predetermined direction and having at least one opening.
  • the medical needle further includes a holding member connected to a needle rear, and the holding member has at least one chamber in communication with the channel.
  • the medical needle further includes at least one groove extending along the predetermined direction.
  • the medical needle further includes a holding member connected to a needle rear, and holding member has at least one chamber in communication with the groove.
  • the cross sectional area varies in a linear or curved manner between one of maximal points and the adjacent one of the minimal points.
  • the vertical cross-section has a shape selected from a group consisting of triangle, quadrangle, hexagon, polygon, circle, and ellipse.
  • the vertical cross-section at the maximal point closer to the needle tip may have the cross-sectional area greater than that at another maximal point closer to the needle rear.
  • the vertical cross-sections at the minimal points may have the same cross-sectional area to each other.
  • the vertical cross-section at the minimal point closer to the needle tip may have the cross-sectional area less than that at another maximal point closer to the needle rear.
  • the cross-sectional area of the vertical cross-section at the minimal point closest to the needle rear may be less than those at any other minimal points.
  • a distance between a pair of the adjacent maximal points may be substantially equal to one between another pair of the adjacent maximal points.
  • a pair of the adjacent maximal points closer to the needle tip may be more spaced than another pair of the adjacent maximal points closer to the needle rear.
  • the medical needle further includes a grating.
  • the needle tip has a radius of curvature of 10 ⁇ m or less.
  • the medical needle further includes a slit extending along the predetermined direction.
  • the medical needle is made, preferably of biocompatible material, and more preferably of biodegradable material.
  • a preferred aspect of the present invention provides a medical needle of biodegradable material extending along a predetermined direction.
  • the medical needle has a triangular cross-section taken along a plane perpendicular to the predetermined direction of which cross-sectional area varies based upon a distance from a needle tip. Also, it includes a first ascending region of which cross-sectional area monotonically increases as being away from the needle tip, a descending region of which cross-sectional area monotonically decreases as being away from the needle tip, and a second ascending region of which cross-sectional area monotonically increases as being away from the needle tip.
  • the first ascending region, the descending region, and the second ascending region subsequently and integrally formed, and the first and second ascending regions have the largest cross-sections with the largest cross-sectional area having substantially the same size and shape to each other.
  • the medical needle further includes at least one additional descending and ascending regions subsequently and integrally formed of biodegradable material, extending in the predetermined direction.
  • Each of the additional descending and ascending regions has the cross-sectional area which monotonically increases and decreases.
  • the smallest cross section in the descending region is similar to the largest cross section in the ascending regions, and the smallest cross section in the descending region has the area greater than one-fourth of the area of the largest cross section in the ascending regions. More preferably, the smallest cross section in the descending region has the area greater than four-ninths of the area of the largest cross section in the ascending regions. Further, the largest cross sections in the first and second ascending regions are spaced away from each other by a gap greater than one 1 ⁇ m.
  • the lancet further includes a constant region integrally formed of biodegradable material between the descending region and the second ascending region, having triangular cross sections taken along any planes perpendicular to the predetermined direction, of which area is constant.
  • the area of the triangular cross sections in the first and second ascending regions are linearly increased at first and second increasing rates, respectively, and the first increasing rate falling within a range between one-sixteenth and one of the second increasing rate. More preferably, the first increasing rate is one-ninth of the second increasing rate.
  • the medical needle may further include a holding region of biodegradable material connected to the second ascending region.
  • the medical needle further includes at least one channel extending in the predetermined direction through at least one of the first and second ascending regions and descending region.
  • the holding region has at least one chamber in communication with the channel.
  • the channel has at least one opening.
  • the channel has at least two openings spaced away from each other by a predetermined gap. More preferably, a plurality of the channels are provided, and the holding region has a plurality of the chambers, each of the chambers being in communication with corresponding one of the channels.
  • the medical needle further includes at least one groove extending in the predetermined direction through at least one of the first and second ascending regions and descending region.
  • the medical needle further includes a plurality of vertical cavities extending in a vertical direction perpendicular to the predetermined direction, and a seal membrane of biodegradable material for sealing the vertical cavities.
  • the seal membrane has the thickness in the vertical direction varying based upon the position of each of the vertical cavities.
  • a preferred aspect of the present invention provides a medical needle including a first ascending region, a descending region, and a second ascending region subsequently and integrally formed of biodegradable material.
  • Those regions extend from a needle tip in a predetermined direction, each of the regions having trapezoidal cross sections taken along any planes perpendicular to the predetermined direction.
  • the first and second ascending regions have the trapezoidal cross sections of which base monotonically increases as being away from the needle tip.
  • the descending region has the trapezoidal cross sections of which base monotonically decreases as being away from the needle tip.
  • the first and second ascending regions have the largest cross section having substantially the same size and shape to each other.
  • the medical needle further includes at least one additional descending and ascending regions subsequently and integrally formed of biodegradable material, extending in the predetermined direction.
  • the smallest cross section in the descending region has the base greater than a half of the base of the largest cross section in the ascending regions. More preferably, the smallest cross section in the descending region has the base greater than two-thirds of the base of the largest cross section in the ascending regions. Further preferably, the largest cross sections in the first and second ascending regions are spaced away from each other by a gap greater than one micron. Further, a continuous curved portion is provided between the descending region and the second ascending region.
  • the medical needle preferably further includes a constant region integrally formed of biodegradable material between the descending region and the second ascending region.
  • the base of the trapezoidal cross sections in the first and second ascending regions are linearly increased at first and second increasing rates, respectively, and the first increasing rate falling within a range between one-fourth and one of the second increasing rate. More preferably, the first increasing rate is one-third of the second increasing rate.
  • the medical needle may further include a holding region of biodegradable material connected to the needle rear
  • a preferred aspect of the present invention provides a medical needle extending along a predetermined direction and having a vertical cross-section taken along a plane perpendicular to the predetermined direction of which cross-sectional area varies based upon a distance from a needle tip.
  • the medical needle includes a plurality of maximal points where the cross-sectional area of the vertical cross-section is locally maximal, and a plurality of minimal points where the cross-sectional area of the vertical cross-section is locally minimal.
  • the vertical cross-section at the maximal point closest to the needle tip has the cross-sectional area not less than those at any other maximal points.
  • a medical needle according to one of the aspects of the present invention reduces pain to the patient and minimizes damage to the pierced portion of the patient.
  • the lancet 1 is used to sample a drop of blood of a patient such as a diabetic for measurement of blood sugar by stinging it onto the appropriate portion (e.g., fingertip) of the patient's body.
  • the lancet 1 extends along the X-direction and has a triangle cross-section as taken along any Y-Z planes.
  • the triangle cross-section includes a base, height, and area varying in accordance with the distance from a lancet tip 11 or the position of the X-axis.
  • the lancet 1 includes a first ascending region (first tissue incising region) 10 of which area is monotonically increased as being away from the tip 11, a first descending region (first friction releasing region) 20 of which area is monotonically decreased as being away from the tip 11, and a second ascending region (second tissue incising region)30.
  • a holding region 40 is connected to the second ascending region 30 of the lancet 1.
  • the lancet 1 extends along a predetermined direction (X-direction) and has a cross-section (referred to as a "vertical cross-section" herein) taken along a plane perpendicular to the predetermined direction of which cross-sectional area varies based upon a distance from a needle tip 11.
  • the lancet 1 includes a plurality of maximal points (Y-Z planes 51, 53) where the cross-sectional area of the vertical cross section is locally maximal, and a minimal point (Y-Z plane 52) where the cross-sectional area of the vertical cross section is locally minimal. Also, it is designed such that the cross-sectional area of the vertical cross-section at the maximal point closest to the needle tip is the same as those at any other maximal points.
  • the lancet 1 of the present invention is formed of any biocompatible materials including polymer macromolecule, bio-macromolecule, protein, and biocompatible inorganic material.
  • the polymer macromolecule includes for example, although not limited thereto, polyvinylchloride, polyethyleneglycol, parylene, polyethylene, polypropylene, polydimethylsiloxane (silicone), polyisoprene, polymethylmethacrylate, polytetrafluoroethylene, polyetherimide, poly(ethylene oxide), polyethyleneterephthalate, polyethylenesuccinate, polybuthyleneterephthalete, polybuthylenesuccinate, poly(buthylenesuccinatecarbonate), poly(phenylene oxide), polyphenylene sufide, polyformaldehyde, polyanhydride, polyamide (6-nyron, 6,6-nyron), polybutadiene, polyvinylacetate, polyvinylalcohol, polyvinylpyrrolidone, polyesteramide, copolymer of MMA, polyacrylonitrile, polysulfone, polyethersulfone, copolymer of styrene, polycarbonate
  • the bio-macromolecule includes for example, although not limited thereto, cellulose, amylum, chitin, chitosan, gelatin, carrageenan, alginic acid, agarose, pullulan, mannan, curdlan, xanthan gum, gellan gum, pectin, xyloglucan, cyamoposis gum, lignin, oligosaccharide, hyaluronic acid, schizophyllan, lentinan, and etc.
  • the protein includes for example, although not limited thereto, collagen, gelatin, keratin, fibroin, glue, sericin, botanical protein, milk protein, egg protein, composite protein, heparin, nucleic acid, and etc. Also, sugar, candy, glucose, maltose, sucrose, and polymer alloy thereof may be used therefor.
  • the biocompatible inorganic material includes for example, although not limited thereto, ceramics, nano-composites ceramics, Al 2 O 3 /ZnO 2 composites ceramics, Si3N4-based nano-composite material, apatite hydroxide, calcium carbonate, carbon, graphite (nano-grafiber), carbon nano-tube (CNT), fullerene composite material, hydroxy-apatite polymer-composite material, cobalt-chrome alloy stainless, and etc.
  • the lancet 1 of the present invention is integrally formed of biodegradable material including for example, poly lactic acid, poly glycolic acid, poly caprolactone, collagen, amylum, hyaluronic acid, alginic acid, chitin, chitosan, cellulose, gelatin, and the compound/composition/copolymer/poly-microparticle thereof.
  • biodegradable material including for example, poly lactic acid, poly glycolic acid, poly caprolactone, collagen, amylum, hyaluronic acid, alginic acid, chitin, chitosan, cellulose, gelatin, and the compound/composition/copolymer/poly-microparticle thereof.
  • the lancet 1 made of biodegradable material such as poly lactic acid
  • the lancet 1 made of biodegradable material is landfilled, advantageously, it is degraded into water and carbon dioxide by microorganism within the soil. Therefore, the lancet 1 made of biodegradable material is better and safer not only for the ecology but also for the patient since even if a portion of the lancet is broken off and remained in the patient's body, it will also be easily degraded within the body.
  • Each of the first and second ascending regions 10, 30 and the first descending region 20 has an outer configuration registered with the respective portion of a particular rectangle pyramid.
  • the rectangle pyramid has a predetermined height (H) as shown in Figs. 2A and 2B , and a rhombic base 14 having first and second predetermined diagonals 12 (L 1 ), 13 (L 2 ), respectively.
  • the base is shaped as a square so that the first and second diagonals 12, 13 have the same length (L 1 - L 2 ).
  • the first ascending region 10 has an outer configuration registered with a first portion of the particular rectangle pyramid taken along the Y-Z plane 51 as shown in Fig. 2B .
  • the first descending region 20 has an outer configuration registered with a second portion of the rectangle pyramid taken along and between the Y-Z planes 51 and 52.
  • the second ascending region 30 has an outer configuration registered with a third portion of the rectangle pyramid taken along and between the Y-Z planes 52 and 53.
  • those regions 10, 20, 30 of the lancet 1 are integrally formed such that each of the regions includes a base surface arranged on the same X-Y plane and the second diagonal arranged on the same line along the x-axis. It should be noted that each of the rectangle pyramid configuring the respective region has substantial the same dimension.
  • the cross-sections taken along any Y-Z planes are triangle and include a base, a height, and an area lineally increasing or decreasing depending upon the distance from a lancet tip 11 or the position of the X-axis.
  • the increase and decrease in size of the regions 10, 20, 30 are explained as being linear functions of the distance from the lancet tip 11 or the position along the x-axis.
  • the base, the height, and the area of the cross-section in those regions may be defined as any non-linear functions such as a second or higher order functions which monotonically increases or decreases.
  • the base, the height, and the area of the regions can be described by a linear or non-linear function monotonically increasing or decreasing as the parameter of the position along the x-axis.
  • the largest cross-sections in the first and second ascending regions 10, 30 having the maximal cross-sectional area i.e., the cross-sections taken along the Y-Z planes 51 and 53
  • the largest cross-sections in the first and second ascending regions 10, 30 having the maximal cross-sectional area has triangular shapes, which are congruent with each other and similar to the smallest cross-section in the first descending regions 20 having the minimal cross-sectional area (i.e., the cross-section taken along the Y-Z plane 52).
  • the lancet 1 of the first embodiment includes at least one additional descending region 20a, 20b and the ascending region 30a, 30b, as shown in Figs. 3 and 4 .
  • the largest cross-sections having the maximal cross-sectional area also have substantially the same shape and size as those of the other largest cross-sections.
  • the lancet 1 illustrated in Figs. 1 to 3 when being penetrated deeply inside the tissue (skin or flesh) of the patient's body, firstly, three of the side lines (sharp ridge lines) 15a, 15b, 15c of the rectangle pyramid incise the peripheral cells around the tip 11 of the first ascending region (first tissue incising region) 10. Then, the bottom surface 14 and the side surfaces 17a, 17b of the first ascending region 10 wedge away the intact (non-incised) tissues into the deep inside.
  • the first incising region 10 cuts and advances into the peripheral cells in a smooth manner.
  • the frictional force is increased between the surfaces 14, 17a, 17b of the first incising region 10 and the peripheral tissue, so that the peripheral tissue may be drawn into the deep inside by the increased frictional force.
  • the frictional force between the peripheral tissue and first descending region (first friction releasing region) 20 is released since the first friction releasing region 20 has the cross-section reducing or shrinking in size as being away from the tip 11.
  • the peripheral tissue drawn inside by the frictional force will be released to the normal position by its elasticity.
  • the peripheral tissue drawn by the first incising region 10 is returned to the original state so that the physical stress applied to the peripheral cells is reduced or minimized.
  • the penetrating process of the lancet 1 is achieved by repeatedly incising the peripheral cells and wedging away the intact tissues by the ascending regions 10, 30, and releasing the frictional force with the peripheral cells by the descending region 20 to replace thereof in its original position.
  • the present invention provides a non-invasive lancet 1 minimizing the pain to the patient by returning the peripheral cells across the substantial area back to the original position and by avoiding the damage of the peripheral cells.
  • one of the peripheral cells has a size of about 10 ⁇ m in general, and in particular, the microcyte in the micro-vessel has the size of 5 ⁇ m.
  • the rectangle pyramid is designed so as to have the first and second diagonals (L 1 , L 2 ) and the height (H) of about 85 to 180 ⁇ m and about 42.5 to 90 ⁇ m, respectively.
  • the largest cross-section in the ascending regions 10, 30 has a triangle shape having a base of about 85 to 180 ⁇ m and a height of about 42.5 to 90 ⁇ m.
  • the lancet 1 has insufficient strength so that it tends to break off between the descending region 20 and the second ascending region 30.
  • the base and the height of the smallest cross-section are approximately less than about 42.5 to 90 ⁇ m and about 21.2 to 45 ⁇ m, respectively, then the lancet 1 is easily broken off.
  • the lancet 1 of the embodiment is designed such that the base and the height of the smallest cross-section are approximately greater than a half of those of the largest cross-section, and thus the smallest cross-section is approximately greater than a quarter (square of a half) of the largest cross-section. More preferably, the lancet 1 is designed such that the base and the height of the smallest cross-section is approximately greater than two-thirds (2/3) of those of the largest cross-section, and thus the smallest cross-section is approximately greater than four-ninths (4/9: square of 2/3) of the largest cross-section. This realizes a stubborn and reliable lancet 1 without breaking off and/or bending so as to secure piercing into the patient's body.
  • the descending region 20 should have the size for releasing the frictional stress of the peripheral cells, i.e., the size of at least one cell, thus as illustrated in Fig. 2A , the gap (D) between the adjacent largest cross-sections taken along the Y-Z planes 51 and 53 is designed to have at least one (1) micron and preferably five (5) microns.
  • the lancet 1 may have a continuous curved portion 58 smoothly connecting the side surface 21 of the descending region 20 and the side surface 37 of the second ascending region 30.
  • the continuous curved portion 58 makes the lancet 1 even stiffer against the stress otherwise concentrated on that portion.
  • the cross-section of the holding region 40 taken along any Y-Z planes is illustrated to be a triangle, it can be a rectangle or any other shapes for appropriate fit to an external holder mechanism (not shown).
  • the lancet 2 of the second embodiment is similar to the lancet 1 of the first embodiment except that it additionally includes a constant region (reinforcing region). Therefore, the duplicated description in detail for the common features will be eliminated.
  • the lancet 2 of the second embodiment has a constant region (reinforcing region) 60 for reinforcing the strength of the lancet 2 between the first descending region 20 and the second ascending region 30 as shown in Figs. 6 and 7 .
  • the constant region 60 has an outer configuration of a triangular prism having a size of X-, Y-, and Z-directions (l x , l y , l z ) with a triangular base 61 that is substantially the same shape and size as the smallest cross-section in the descending region 20.
  • the constant region 60 has a triangle cross-section having a base (1 y ) and a height (1 z ) as taken along any Y-Z planes.
  • the base and the height (ly, 1 z ) of the constant region 60 are designed to be approximately greater than a half, preferably a two-thirds (2/3) of those of the largest cross-section(L 1 , H), respectively, i.e., l y ⁇ L 1 / 2 , l z ⁇ H / 2 ; and preferably, l y ⁇ 2 ⁇ L 1 / 3 , l z ⁇ 2 ⁇ H / 3.
  • This design reinforces the strength between the descending region 20 and the second ascending region 30 so as to realize a more stubborn lancet 2.
  • the lancet 2 of the second embodiment may include at least one additional descending region 20a, 20b, the constant region 60a, 60b, and the ascending region 30a, 30b, as illustrated in Figs. 8 and 9 .
  • the lancet 3 of the third embodiment is similar to the lancet 1 of the first embodiment except that the lancet tip is formed sharper than that of the first embodiment. Therefore, the duplicated description in detail for the common features will be eliminated.
  • the first and second ascending region 10, 30 are designed so as to have the triangular cross-section taken along any Y-Z planes, of which height and base are increased linearly as being away from the tip 11 with gradients (increasing rates) indicated by a solid line 55 and a one-dotted line 54, respectively.
  • the increasing rate (k) of the height and base of the first ascending region 10 indicated by the solid line 55 varies from an increasing rate (k 1 ) indicated by one imaginary line 56 to another increasing rate (k 2 ) indicated by another imaginary line 57, i.e., k 2 57 ⁇ k 55 ⁇ k 1 56 .
  • the imaginary line 56 is parallel to the one-dotted line 54 of the second ascending region 30 having the increasing rate (k 0 ), and the other imaginary line 57 is approximately a quarter of the increasing rate (k 0 ), i.e., k 0 / 4 57 ⁇ k 55 ⁇ k 0 56 .
  • the increasing rate of the cross-section (area) of the second ascending region 30 is represented by (K 0 )
  • the increasing rate (K) of the cross-section (area) of the first ascending region 10 falls within a range between one-sixteenth (1/16; square of a quarter) and one of the second ascending region 30, i.e., K 0 / 16 ⁇ K ⁇ K 0 .
  • the first ascending region has the length in the X-direction varying between L 1 /2 to 2L 1 , preferably 3L 1 /2, and also the tip angle ( ⁇ ) indicated in Fig. 10B varies between about 14 degree to 45 degrees, preferably is about 18.3 degree.
  • the height and the base of the cross-section in the first ascending region 10 are more moderately increased than those in the second ascending region 30 so that lancet tip 11 of the embodiment is sharper and more elongated. This contributes the lancet 3 of the third embodiment to be penetrated more smoothly into the deep inside with less resistance, thereby further reducing the pain to the patient.
  • the lancet of foregoing embodiments can be manufactured, for example, by use of ROBONANO ⁇ -0iA® commercially available from FUNAC Ltd. in Yamanashi Pref., JAPAN.
  • the lancet 101 of the first modification is similar to the lancets 1, 2, 3 of the first to third embodiments except that at least one channel and chamber are provided within the lancet. Therefore, the duplicated description in detail for the common features will be eliminated.
  • the lancet 101 of the first modification includes at least one channel 71 extending through the incising regions 10, 30 and the releasing region 20 of the lancet 101 as illustrated in Fig. 11A .
  • the holding region 40 includes at least one chamber 81 in communication with the channel 71, which has the rectangular cross-section taken along any Y-Z planes as shown in Fig. 11C .
  • the lancet 101 has at least one opening 72 close to the tip 11, extending through any appropriate surfaces such as the bottom surface 73 of the descending region 20.
  • the lancet 101 having the channel 71 and the chamber 81 can be used in various applications.
  • a pair of electrodes (not shown) spaced away from each other may be arranged within the channel 71 and also a bio-sensor (not shown) such as a Micro Total Analysis System ( ⁇ -TAS) may be received in the chamber 81.
  • ⁇ -TAS Micro Total Analysis System
  • the lancet 101 of the first modification can be used as an injection needle.
  • a micro-pump (not shown) is connected with the chamber 81, and once the lancet 101 is pierced into the body, negative pressure is applied to the chamber 81 so as to easily sample a drop of blood.
  • the lancet 101 may include a groove 74 extending along the X-direction on the bottom surface 73 as illustrated in Fig. 12 .
  • the lancet 101 may include a pair of electrodes arranged within the groove 74 and also a bio-sensor received in the chamber 81 to analyze the desired component of blood.
  • the groove 74 in cooperation with the peripheral tissue also defines the capillary tube so that blood plasma is filled sufficiently within the groove 74.
  • the lancet 101 of the modification may include a plurality of channels extending in the X-direction and a plurality of chambers in the holding region 40, each of channels separately communicating with corresponding one of the chambers (two channels 75, 76 and two chambers 82, 83 are shown in Fig. 13 ). Also, a plurality of openings 77a-77c, and 78a-78c are formed adjacent the tip 11, for example, extending through the side surfaces of the regions 10, 20, 30 as illustrated in Figs. 13A and 13B . Each of the channels 75, 76 may receive the independent electrode pairs and also each of the chambers 82, 83 may include a different bio-sensors therein for analyzing a plurality types of blood components.
  • plural kinds of medicaments may be reserved within the chambers 82, 83 for gradually releasing the medicaments into the patient's body through the openings 77, 78.
  • each of the openings 77, 78 may be sealed by a sheet (not shown) made of the same biodegradable material so as to allow the medicaments to be gradually released a predetermined time after the lancet 101 is stuck in the tissue of the patient.
  • the thickness of the sheets may be changed depending upon the channels 75, 76 so that the timing for gradual release of the medicaments can be controlled.
  • the adjacent openings 77, 78 are spaced away from each other by a predetermined gap.
  • each of the electrodes is assembled to be extruded through the respective one of openings 77, 78, then the distance between the electrodes is defined exactly, allowing the fluid between the electrodes to be analyzed in a more precise manner.
  • another example is where a pair of fiber optics are extruded through the openings 77b and 77c so that beams from each of the fiber optics intersect each other, then the fluid at the intersection of the beam can be inspected more accurately due to the precisely defined geometry.
  • the lancet 102 of the second modification is similar to the lancets 1, 2, 3 of the first to third embodiments except that a vertical cavity and a seal membrane for sealing the vertical cavity are provided within the lancet. Therefore, the duplicated description in detail for the common features will be eliminated.
  • the lancet 102 of the second modification includes at least one vertical cavity (four vertical cavities 91a-91d are shown in Figs. 14A, 14B ) extending in a vertical direction (Z-direction) and a seal membrane 92 for sealing the vertical cavity.
  • the vertical cavity 91 receives a micro-particle or fluid containing medicament therein.
  • the seal membrane 92 is made of biodegradable material so that in conjunction with the lancet 102, it seals the vertical cavity to secure the medicament therein without slipping off from the vertical cavity 91.
  • the seal membrane 92 is designed such that it has the thickness in the Z-direction varying based upon the position of the vertical cavities 91a-91d. In one example shown in Fig. 15A , the seal membrane 92 has the thickness tapered towards the tip 11, and in another example shown in Fig.
  • the seal membrane 92 is stepped such that it is the thinnest at the cavity 91a, and the second thinnest at the cavity 91b, and the thickest at the last cavity 91d. This structure controls the timing for gradual release of the medicament received in the vertical cavities 91a-91d.
  • the channel 71, the chamber 81, the openings 77, 78, and the vertical cavities 91a-91d of the first and second modifications are formed with use of a laser device such as an excimer laser emitting laser beam having adjustable power.
  • the lancet 4 of the fourth embodiment is similar to the lancet 1 of the first embodiment except that while the latter has the triangular cross-section taken along any Y-Z planes, the former has the trapezoidal cross-section taken along any Y-Z planes. Therefore, the duplicated description in detail for the common features will be eliminated.
  • the lancet 4 of the present embodiment has the trapezoidal, rather than triangular, cross-sections taken along any Y-Z planes.
  • the trapezoid has the base (i.e., each of the upper and lower bases) varying in accordance with the distance from the lancet tip 11 or the position in the X-direction, and the height (H) that is constant.
  • the lancet 4 of the present embodiment includes first and second ascending regions (first and second tissue incising regions) 10, 30, of which trapezoidal cross-sections taken along any Y-Z planes has the base monotonically increasing as being away from the tip 11, and a first descending region (first friction releasing region) 20 of which trapezoidal cross-sections taken along any Y-Z planes has the base monotonically decreasing as being away from the tip 11.
  • the holding region 40 is connected with the subsequent ascending region.
  • the lancet 4 of the present invention is integrally made of the aforementioned biocompatible material, or more preferably, made of the biodegradable material so that it can readily be disposed and also retained in the patient's body.
  • the largest trapezoidal cross-section of the first and second ascending regions 10, 30 have bases of substantially the same length.
  • the height (H) of the trapezoidal cross-section is preferably short (the lancet 4 is thin), the height (H) has to be taller than a predetermined dimension for ensuring sufficient strength of the lancet 4.
  • the lancet 4 of the embodiment preferably has the thickness (H) greater than about one-eighth of the base of the largest cross-section, i.e., the first diagonal (L 1 ) of the rectangular pyramid (i.e., H ⁇ L 1 /8).
  • the base of the smallest cross-section is preferably greater than a half, and more preferably greater than about two-thirds of the largest cross-section.
  • the largest cross-sections in first and second ascending regions 10, 30 adjacent to each other is spaced away preferably by a predetermined gap (D) of at least 1 micron.
  • the lancet 4 of the fourth embodiment may include at least one additional descending region and ascending region integrally formed with the second ascending region 20. Also, similar to the second embodiment, the lancet 4 of the fourth embodiment may include at least one additional constant (reinforcing) region having the cross-section of substantially the constant area, which is formed between the descending and ascending regions.
  • the first ascending region 10 of the lancet 4 is designed sharper such that the base of the trapezoidal cross-section increases gently.
  • the increasing rate of the base of the trapezoidal cross-section in the first ascending region 10 falls within a range between about one-fourth and one of the increasing rate of the trapezoidal cross-section in the second ascending region 30.
  • the lancet 4 of the fourth embodiment is sharp so that it can easily be penetrated into the tissue, minimizing the pain to the patient.
  • Fig. 19A is a perspective view of the lancet 5 similar to Fig. 3 (lancet 1) and Fig. 10A (lancet 3).
  • Fig. 19B-19D are front elevational, side, and top plan views of the lancet 5 similar to Figs. 4A-4C (lancet 1).
  • the lancet 5 of the fifth embodiment is similar to the lancet 1 of the first embodiment except that while the latter has the triangular cross-section taken along any Y-Z planes, the former has a semi-circle cross-section taken along any Y-Z planes. Therefore, the duplicated description in detail for the common features will be eliminated.
  • the lancet 5 of the present invention extends along the predetermined direction (X-direction) and includes cross-sections taken along a plane (Y-Z plane) perpendicular to the predetermined direction (referred to as a "vertical cross-section” herein), of which cross-sectional area regularly varies based upon the distance from the needle tip 11. Also, the lancet 5 includes a plurality of maximal points 22a-22c where the cross-sectional area is locally maximal, and a plurality of minimal points 23a-23c where the cross-sectional area is locally minimal. In Figs. 19A-19D , three of the maximal and minimal points are illustrated, any plural number of the maximal and minimal points may be provided.
  • the lancet 5 is designed such that the vertical cross-section at the maximal point 22a closest to the needle tip 11 has the same cross-sectional area as those at any other maximal points 22b, 22c, and the vertical cross-section at the minimal point 23a closest to the needle tip 11 has the same cross-sectional area as those at any other minimal points 23b, 23c. Also, in the lancet 5 shown in Figs. 19A-19D , a distance (D) between a pair of the adjacent maximal points, e.g., 22a and 22b, is substantially equal to one between another pair of the adjacent maximal points e.g., 22b and 22c.
  • the cross-sectional area of the vertical cross-section varies in a linear manner between one of maximal points and the adjacent one of the minimal points, e.g., between 22a-23a and 23a-22b.
  • the cross-sectional area of the vertical cross-section may also vary in a curved manner between one of maximal points and the adjacent one of the minimal points.
  • the lancet 5 so structured When the lancet 5 so structured is penetrated inside the tissue (skin or flesh) of the patient's body, as illustrated in Fig. 19C , it wedges away the peripheral cells around the tip 11 of the first ascending region (first tissue incising region) 10. Since the frictional force between the first ascending region 10 and the peripheral tissue is more significant, as the lancet 5 advances into the tissue, the peripheral tissue may be drawn into the deep inside by the frictional force.
  • the lancet 5 further advances after the first ascending region 10 sinks within the tissue, since the cross-sectional area of the first descending region (first friction releasing region) 20 is decreased, thus, the frictional force between the lance 5 and the peripheral tissue is reduced.
  • This allows the peripheral cells to return to the normal position due to its elasticity.
  • the peripheral cells drawn by the first ascending region 10 is returned to the original position and released from the physical stress applied thereto.
  • the second ascending region 30 advances into the tissue, it also wedges away the peripheral cells for penetration.
  • the vertical cross-section at the maximal point 22a closest to the needle tip 11 is designed to have the same cross-sectional area as those at any other maximal points 22b, 22c, the peripheral tissue can avoid suffering from being stretched (stressed) beyond the degree as required for penetration by the descending regions such as second ascending region 30.
  • the angle ( ⁇ ) between the X-axis and the side surface of the descending region 20 is greater than the angle ( ⁇ ) between the X-axis and the side surface of the ascending region 30.
  • the present invention provides a non-invasive lancet 5 reducing the pain to the patient by returning the peripheral cells across the substantial area back to the original position and by minimizing the damage of the peripheral cells.
  • the lancet 5 of the fifth embodiment has the vertical cross-section of a semi-circle configuration taken along any Y-Z planes.
  • the lancets 103, 104, 105, 106 of the third to sixth modifications are similar to the lancet 5 of the fifth embodiment except that they have the vertical cross-sections of a circle, oval, rectangular, hexagonal configurations, as illustrated in Figs. 21A-21C , 22A-22C , 23A-23C , and 24A-24C , respectively.
  • the lancets 103, 104, 105, 106 of the third to sixth modifications has the same advantage as the lancet 5 of the fifth embodiment, i.e., substantially reducing the pain of the patient and minimizing the unrecoverable damage to the peripheral cells across a substantial area.
  • Fig. 25 is a top plane view of the lancet 6 similar to Fig. 4C (lancet 1) and Fig. 10C (lancet 3).
  • the vertical cross-sections at the maximal points have the same cross-sectional area as each other.
  • the vertical cross-section at the maximal point 22a closest to the needle tip 11 has the cross-sectional area greater than those at other maximal points 22b, 22c, in particular, the cross-sectional area of the vertical cross-sections at the maximal points are smaller as the vertical cross-section is closer to the lancet rear 18.
  • the lancet 6 of the sixth embodiment has a structure similar to that of the lancet 1, the duplicated description in detail for the common features will be eliminated.
  • the distances (D1-D5) between a pair of the adjacent maximal points 22a-22c of the lancet 6 are shorter as closer to the lancet rear 18.
  • the cross-sectional area of the vertical cross-sections at the minimal points 23a-23d are constant.
  • lancet 6 when the lancet 6 is pierced into the body, i.e., when the lancet tip 11 is in the tissue and the holing member 40 is supported by a user, a significant stress is likely concentrated on the lancet rear 18, and lancet 6 may be broken off at the minimal point 23d adjacent to the lancet rear 18.
  • the lancet 6 since the lancet 6 is designed such that the cross-sectional area at each of the minimal points 23a-23d is constant, it can be stiff at the minimal point 23d adjacent to the lancet rear 18 to realize a safer lancet 6.
  • the lancet 107 of the seventh modification is designed such that while the cross-sectional area of the vertical cross-sections at the maximal points 22a-22c are constant, the cross-sectional area of the vertical cross-sections at the maximal points 23a-23d are smaller as the vertical cross-section is closer from the tip 11 to rear 18 (in the reverse direction of the X-axis).
  • the vertical cross-section 23d has the cross-sectional area greater than those at the other vertical cross-sections 23a-23c. Therefore, according to the seventh modification, the lancet 107 can be stiffer at the minimal point 23d adjacent to the lancet rear 18 and safer than the lancet of the sixth embodiment.
  • the eighth modification of the sixth embodiment will be described herein.
  • the cross-sectional area of the vertical cross-sections at the maximal points 22a-22c are constant, and the cross-sectional area of the vertical cross-sections at the minimal points 23a-23c except 23d are constant.
  • the cross-sectional area only at the minimal point 23d closest to the lancet rear 18 is smaller than those at the other minimal points 23a-23c.
  • the lancet 108 in the lancet 108 so structured, after it is pierced into the tissue, it may be intentionally broken off at the minimal point closest to the lancet rear 18 to allow the broken portion of the lancet 108 being remained within the tissue.
  • the lancet 108 In case where the lancet 108 is used to be remained in the tissue, it should be formed of the biodegradable material such as polylactide.
  • the lancet 107 and 108 has the same advantage as the lancet 6, substantially reducing the pain of the patient and minimizing the unrecoverable damage to the peripheral cells.
  • Fig. 28A is a bottom plane view of the lancet 109 of the ninth modification when viewed from the bottom to the top (in the Z-direction), and Fig. 28B is a cross-sectional view taken along the X-Z plane.
  • the lancet 109 includes a grating 24 formed on the bottom surface 73.
  • the grating 24 has a distance (pitch) (P) between a pair of adjacent peaks 25, and inclined surfaces 26 e.g., at 45 degrees with the X-axis.
  • Fig. 28C The interface between blood 27 and atmosphere follows the curved trace as shown in Fig. 28C , which may vary depending upon surface tension between blood in a liquid form and material of the inclined surfaces 26.
  • the grating 24 is made of polylactide of higher hydrophilicity, more amount of blood is adhered on the grating 24.
  • An incident beam 28 irradiated by a laser radiator (not shown) from the above reflects at the inclined surfaces 26 twice, and the reflected beam 29 returns to a laser detector (not shown).
  • the distance between the incident beam 28 and the reflected beam 29 is represented as (d), the laser beam path is uniquely defined by the distance (d).
  • the laser beam transmits into blood by the distance (d), causing the phase shift of the laser beam to be detected.
  • Measurement of such phase shift finds the content of keton body and blood sugar in blood.
  • the particulate body such as erythrocyte is adhered on the grating 24, the measurement of blood sugar may include error. Therefore, the pitch (P) is preferably shorter than the size of the erythrocyte to avoid the adhesion thereof, for example, in the range between 1 to 25 ⁇ m.
  • the laser measurement device (not shown) is used to instantly measure the content of the keton body and blood sugar in blood.
  • the lancets 110 illustrated in Figs. 29A and 29B which are top plane views similar to Figs. 4C and 10C , includes the lancet tips 11 having the curvature radius of 10 ⁇ m and 3 ⁇ m, respectively.
  • the tip 11 of a lancet or injection needle is round and not sharp, it gives more pain as it is penetrated within the tissue. Thus, it is well-known by those skilled in the art that the sharper tip gives the less pain.
  • the dedicated study of the present inventors has revealed that if the lancet 110 with the tip 11 having the curvature radius of approximately 10 ⁇ m or less is pierced into the skin, the pain can be substantially reduced.
  • the lancet 110 of the tenth modification is designed such that it includes the tip 11 having the curvature of the radius (R 1 ) of approximately 10 ⁇ m or less as shown in Fig. 29A , and preferably having the curvature of the radius (R 2 ) of approximately 3 ⁇ m or less as shown in Fig. 29B .
  • the lancet 110 can be realized to gives less pain to the patient.
  • the lancet so formed can be used as a sort of a dimension gauge when it is pierced within the tissue. Alternatively, it may be marked or colored at the position away from the tip 11 by a predetermined distance to clearly indicate the distance from the tip 11.
  • Figs. 30A-30C are front elevational, side, and top plan views of the lancet 111 similar to Figs. 4A-4C .
  • the lancet 111 of the eleventh modification is formed by combining a pair of lancets 1 of Figs. 4A-4C with the holding members being secured to each other, and includes a slit 31 between the pair of the lancets 1a, 1b.
  • Figs. 31A-31C are front elevational, side, and top plan views of the lancet 112 similar to Figs. 19B-19D .
  • the lancet 112 of the twelfth modification is formed by combining a pair of lancets 5 of Figs. 19B-19D with the holding members being secured to each other, and includes a slit 31 between the pair of the lancets 5a, 5b.
  • the lancets of the eleventh and twelfth modifications have the same advantage as the lancets 1, 5.
  • blood or lymph is drawn through the narrow slit 31 towards the holing member 40 by capillary force.
  • blood plasma, cells, and proteins contained in blood can easily be sampled.
  • each of the maximal and minimal points, the side lines, and the tips are illustrated as being discontinuous surfaces in the drawings of the above-described embodiments and modifications, as understood by those skilled in the art, each of them may be configured to have smooth curved surfaces, like the continuous surface 58 of Fig. 5 .

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EP04807140A 2003-12-19 2004-12-16 Medical needle and medical device Active EP1695664B1 (en)

Applications Claiming Priority (3)

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JP2003422999 2003-12-19
US10/784,877 US7361182B2 (en) 2003-12-19 2004-02-24 Medical lancet
PCT/JP2004/018781 WO2005058162A1 (ja) 2003-12-19 2004-12-16 医療用針および医療用デバイス

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US7740621B2 (en) 2010-06-22
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WO2005058162A1 (ja) 2005-06-30
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CN1882282A (zh) 2006-12-20
KR101149852B1 (ko) 2012-05-25
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US20050149088A1 (en) 2005-07-07
DE602004031361D1 (de) 2011-03-24

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